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Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy

18 Years
80 Years
Not Enrolling
Depression, Stage I Breast Cancer, Stage IIIA Breast Cancer, Nutrition, Stage II Breast Cancer, Psychosocial Effects/Treatment, Quality of Life

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Trial Information

Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy

OBJECTIVES: I. Evaluate the relative contributions of factors that may lead to weight gain
in breast cancer patients receiving adjuvant chemotherapy. Factors examined include:
Hormonal and growth factor status (follicle stimulating hormone, total, bound, and free
estradiol, androgens, sex hormone binding globulin, thyroid hormones, prolactin,
insulin-like growth factors I and II, and plasma leptin) Factors affecting energy intake or
expenditure (oral intake, physical activity, and resting metabolic rate) Psychological
factors (depression and quality of life) II. Evaluate the effect of chemotherapy on
hormonal and growth factor status in these patients.

III. Assess the impact of chemotherapy on bone marrow density in these patients.


Data is collected from women diagnosed with primary breast cancer at 3 points (5 visits):
(i) after breast cancer surgery, but before chemotherapy begins (2 visits to NIH day
hospital 1 week apart); (ii) 2-3 weeks after chemotherapy has ended (2 visits, 1 week
apart); and (iii) 6 months after chemotherapy has ended (1 visit). Tests conducted during
these visits include evaluation of blood for hormones, growth factors, and leptin; body
composition by DXA; visceral and subcutaneous abdominal adipose tissue by an axial CT scan;
and evaluation of resting metabolic rate and daily energy expenditure by a single
administration of doubly labeled water at visits "a" and "b" during data collection
timepoints 1 and 2. Questionnaires assessing epidemiologic risk factors for breast cancer,
dietary intake, physical activity, depression, and quality of life are also administered at
the three timepoints.


A total of 140 patients will be accrued for this study within 1-2 years.

Inclusion Criteria


--Disease Characteristics-- Histologically proven newly diagnosed stage I, II, or
resectable IIIA primary breast cancer Scheduled to receive chemotherapy No distant
metastases --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: See
Disease Characteristics No concurrent neoadjuvant chemotherapy Endocrine therapy: No
concurrent thyroid medication Radiotherapy: No concurrent radiotherapy Surgery: See
Disease Characteristics No prior oophorectomy Other: No concurrent alternative medicines
alone No concurrent participation in dietary and/or exercise weight loss programs
--Patient Characteristics-- Age: 18 to 80 Sex: Female Menopausal status: Premenopausal or
postmenopausal Performance status: Not specified Life expectancy: Not specified
Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No
physical or mental disability that would preclude completing questionnaires No prior or
concurrent diabetes mellitus No prior hypothyroidism or hyperthyroidism

Type of Study:


Study Design:

Time Perspective: Prospective

Principal Investigator

Noreen Aziz

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

April 2007

Related Keywords:

  • Depression
  • Stage I Breast Cancer
  • Stage IIIA Breast Cancer
  • Nutrition
  • Stage II Breast Cancer
  • Psychosocial Effects/Treatment
  • Quality of Life
  • adult solid tumor
  • body system/site cancer
  • breast cancer
  • cancer
  • cancer-related problem/condition
  • depression
  • depression and suicide
  • nutrition
  • psychosocial effects/treatment
  • quality of life
  • solid tumor
  • stage I breast cancer
  • stage I, II, and IIIA breast cancer
  • stage II breast cancer
  • stage III breast cancer
  • stage IIIA breast cancer
  • stage IIIB, IV, recurrent, and metastatic breast cancer
  • stage, breast cancer
  • Breast Neoplasms
  • Depression
  • Depressive Disorder



Cancer Prevention Studies Branch Bethesda, Maryland  20892